Search Results

This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.

This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.

The provided document is a 510(k) summary for a "Love Guard" Male Latex Condom and does not describe a study involving algorithms, human readers, or AI. Therefore, many of the requested bullet points are not applicable.

However, it does provide information about the acceptance criteria and how the device meets some of them by comparing it to a predicate device.

Here's a breakdown of the relevant information:

1. A table of acceptance criteria and the reported device performance

The document compares the "Love Guard" Condom to a predicate device ("Lifestyles" Condom) across several features, implying these are the acceptance criteria for substantial equivalence. The reported performance of the "Love Guard" condom is listed alongside.

Study that proves the device meets the acceptance criteria:

The document states that the "Love Guard" Male Latex Condom is designed to conform to established American and international voluntary standards, including ASTM D3492 and ISO 4074. It also explicitly states: "Its design is in conformance with ASTM Latex Condom Standard D3492." The comparison table above demonstrates that its physical attributes are similar to, or within acceptable ranges of, the predicate device. The claim of "no significant difference between the 'Love Guard' Male Latex Condom and the predicate device in the areas of safety and effectiveness" is based on these similarities and conformance to standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes a comparison to a predicate device and adherence to standards, but does not detail specific testing methodologies or sample sizes for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. This document pertains to the physical and functional characteristics of a male latex condom, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (condom), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is not an algorithmic or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context would be defined by the specifications outlined in the referenced voluntary standards (ASTM D3492 and ISO 4074) and the characteristics of the legally marketed predicate device. For example, standards would define acceptable ranges for dimensions, burst pressure, and burst volume.

8. The sample size for the training set

This information is not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable.

Ask a specific question about this device